Dato-DXd and rilvegostomig after surgery for high-risk muscle invasive bladder cancer
Tests Dato-DXd with rilvegostomig against standard care in adults after cancer surgery.
Plain-language title generated from the registry record
Registry title: An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Key facts
- Where
- Bangkok and Hat Yai, ThailandSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with muscle invasive urothelial cancer at high risk of coming back after surgery to remove it. It compares Dato-DXd with rilvegostomig against standard care.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Muscle invasive urothelial cancer of the bladder or upper tract, fully removed by surgery 28 to 120 days before randomisation, with high risk of recurrence and no sign of disease now.
- Earlier treatment
- No chemotherapy or radiation after the surgery. Some people may have had treatment before surgery. No earlier TROP2-directed therapy, deruxtecan-based ADC, anti-cancer vaccine or anti-TIGIT therapy.
- Biomarker or test result
- An archived tumour sample from the surgery must be available for central testing.
Main reasons for not taking part
- Tumour that is mostly high grade neuroendocrine carcinoma
- Partial removal of the bladder or kidney
- Severe or uncontrolled illness, including lung disease (ILD/pneumonitis), heart conditions or autoimmune disorders
- History of organ transplant or allogeneic stem cell transplant
- Active hepatitis B or C, or HIV that is not well controlled
Read by machine on 9 November 2026.
Where in Thailand
- BangkokHospital not named in the registryNot yet recruiting
- Hat YaiHospital not named in the registryNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07720284
- Record updated
- 22 July 2026
- Original description
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.Read full original descriptionShow less
A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
Study details:
Duration: ~78 months (6.5 years) from FSI to last subject visit Treatment length: up to ~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3
Inclusion: Participant must be > 18 years of age at the time of signing the ICF; Histologically confirmed MIUC of the bladder or upper tract; Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease; Pathologic evidence of urothelial carcinoma at high-risk of recurrence and; not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage; completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage; No evidence of disease at screening,; ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation; Minimum life expectancy of > 12 weeks at time of screening; An archival surgical tumour sample must be available pre-randomisation for central testing; Adequate organ and bone marrow function within 28 days before randomisation.
Exclusion: Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma; History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention and of low potential risk for recurrence; Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years; Prior exposure to TROP2-directed therapies, other ADCs with deruxtecan, therapeutic anti-cancer vaccines, anti-TIGIT therapy or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms; Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation; Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy; Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse; History of clinically significant corneal disease; Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baseline. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care; Active or uncontrolled hepatitis B or C virus infection; Known HIV infection that is not well controlled; Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation; History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening; Uncontrolled or significant cardiac conditions; Known history of severe hypersensitivity reactions to any study drug; Any tumour with predominant or pure high grade neuroendocrine carcinoma component; Has clinically severe pulmonary function compromise; Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening; Not eligible to receive at least one of SoC according to local regulations/approvals; Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.